Reducing Antibiotic Resistance: Improved Diagnostics and Treatment for Uncomplicated Urinary Tract Infection in General Practice, Denmark
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Tract Infections
- Sponsor
- University of Copenhagen
- Enrollment
- 377
- Locations
- 1
- Primary Endpoint
- The proportion of patients receiving correct treatment
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine whether point-of-care susceptibility testing improve correct choice of antibiotics, clinical and microbiological outcome in patients with uncomplicated urinary tract infection in general practice compared to point-of-care urine culture.
Detailed Description
700-900 patients with symptoms of uncomplicated urinary tract infection, consecutively contacting their GP, randomized to either point of care test (POCT) urine culture and empirical treatment or POCT urine culture and susceptibility testing and targeted treatment. Patients are included until 440 with verified positive cultures are included. The two groups are compared with regard to correct choice of antibiotics, clinical remission and microbiological cure rates.
Investigators
Anne Holm
MD PhD-student
University of Copenhagen
Eligibility Criteria
Inclusion Criteria
- •Female adult patients
- •18 years or older
- •Presenting at their GP with dysuria
- •Frequency or urgency, which have been present for 7 days or less and where the GP suspects uncomplicated UTI.
- •Patients should be able to deliver a mid-stream urine sample, to provide informed consent and be willing and able to fill out a symptom diary.
Exclusion Criteria
- •Negative dipstick analysis
- •Complicated urinary tract infection
- •Known pregnancy
- •Severe systemic symptoms, high fever, flank pain
- •Recent bladder surgery (within past 4 weeks)
- •Urinary tract abnormalities
- •Serious systemic disease
- •Life-threatening cancer
- •Insulin dependent diabetes
- •Long-term corticosteroid treatment
Outcomes
Primary Outcomes
The proportion of patients receiving correct treatment
Time Frame: 12 months
Correct treatment defined as: 1. If an antibiotic is given, there is significant growth of one or more organisms in the gold standard, which all are sensitive to the given antibiotic. The antibiotic must be one of the recommended first-choice treatments unless the organism(s) is/are resistant to or the patient is allergic 2. If no antibiotic is given, there is no significant growth in the gold standard
Secondary Outcomes
- The proportion of patients who are asymptomatic the 4'th day of treatment (clinical cure)(14 months)
- -The proportion of patients with no significant bacteriuria on day 14 (bacteriological cure)(14 months)
- Accuracy of point-of-care urine culture and susceptibility testing(14 months)